BEUDAMED
    FDA Adverse Event Injury Summary report: N

    840 VENTILATOR

    MDR report key: 3801690 · Received April 25, 2014

    Report

    Report Number
    8020893-2014-00998
    Event Type
    Injury
    Date Received
    April 25, 2014
    Report Date
    March 28, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED VENTILATOR AND FOUND THAT THE KEYBOARD KNOB WAS INTERMITTENTLY NOT RESPONDING. THE CSE REPLACED GRAPHIC USER INTERFACE (GUI) KEYBOARD. THE CSE VERIFIED VENTILATOR PASSES ALL TESTS AND CALIBRATIONS AS OUTLINED BY THE SERVICE MANUAL. (B)(4).

    Description of Event or Problem · 1

    A REPORT RECEIVED FROM THE USA STATED AN 840 VENTILATOR EXPERIENCED AN UNRESPONSIVE KEYBOARD KNOB, WHILE BEING USED ON A PT. THE PT WAS REMOVED FROM THE DEVICE AND PLACED ON AN ALTERNATIVE VENTILATOR. THERE WAS NO REPORT OF PT INJURY. THE DATE OF THE EVENT IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250330 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR 840

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention